EFFORT Extension Study (EFFORT-Ex)

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The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment

The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.

The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.

Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.

The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.

The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.

Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.

Study Arms

Experimental: ROADMAP

Intervention: Drug: telbivudine (ROADMAP)

Active Comparator: SOC (Standard of Care)

Intervention: Drug: Telbivudine (Standard of Care)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Unknown status

Estimated Enrollment ICMJE

576

Estimated Completion Date

December 2015

Estimated Primary Completion Date

August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Treated with telbivudine or combined with adefovir in EFFORT study

Patients are willing to participate in the extension study

Patients provide information consent form

Exclusion Criteria:

Adjustment of poor compliance by investigators

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ICMJE

NCT01529255

Other Study ID Numbers ICMJE

MOH-05

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Nanfang Hospital of Southern Medical University

Study Sponsor ICMJE

Nanfang Hospital of Southern Medical University

Collaborators ICMJE

Major Science and Technology Special Project of China Eleventh Five-year